[Federal Register Volume 76, Number 22 (Wednesday, February 2, 2011)]
[Rules and Regulations]
[Pages 5696-5704]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-1779]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[EPA-HQ-OPP-2009-0980; FRL-8861-1]
Fluazifop-P-butyl; Pesticide Tolerances
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
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SUMMARY: This regulation establishes tolerances for residues of
fluazifop-P-butyl in or on multiple commodities which are identified
and discussed later in this document. Syngenta Crop Protection, Inc.,
requested these tolerances under the Federal Food, Drug, and Cosmetic
Act (FFDCA).
DATES: This regulation is effective February 2, 2011. Objections and
requests for hearings must be received on or before April 4, 2011, and
must be filed in accordance with the instructions provided in 40 CFR
part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION).
ADDRESSES: EPA has established a docket for this action under docket
identification (ID) number EPA-HQ-OPP-2009-0980. All documents in the
docket are listed in the docket index available at http://www.regulations.gov. Although listed in the index, some information is
not publicly available, e.g., Confidential Business Information (CBI)
or other information whose disclosure is restricted by statute. Certain
other material, such as copyrighted material, is not placed on the
Internet and will be publicly available only in hard copy form.
Publicly available docket materials are available in the electronic
docket at http://www.regulations.gov, or, if only available in hard
copy, at the OPP Regulatory Public Docket in Rm. S-4400, One Potomac
Yard (South Bldg.), 2777 S. Crystal Dr., Arlington, VA. The Docket
Facility is open from 8:30 a.m. to 4 p.m., Monday through Friday,
excluding legal holidays. The Docket Facility telephone number is (703)
305-5805.
FOR FURTHER INFORMATION CONTACT: Susan Stanton, Registration Division
(7505P), Office of Pesticide Programs, Environmental Protection Agency,
1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone
number: (703) 305-5218; e-mail address: stanton.susan@epa.gov.
SUPPLEMENTARY INFORMATION:
I. General Information
A. Does this action apply to me?
You may be potentially affected by this action if you are an
agricultural producer, food manufacturer, or pesticide manufacturer.
Potentially affected entities may include, but are not limited to those
engaged in the following activities:
Crop production (NAICS code 111).
Animal production (NAICS code 112).
Food manufacturing (NAICS code 311).
Pesticide manufacturing (NAICS code 32532).
This listing is not intended to be exhaustive, but rather to
provide a guide for readers regarding entities likely to be affected by
this action. Other types of entities not listed in this unit could also
be affected. The North American Industrial Classification System
(NAICS) codes have been provided to assist you and others in
determining whether this action might apply to certain entities. If you
have any questions regarding the applicability of this action to a
particular entity, consult the person listed under FOR FURTHER
INFORMATION CONTACT.
B. How can I get electronic access to other related information?
You may access a frequently updated electronic version of EPA's
tolerance regulations at 40 CFR part 180 through the Government
Printing Office's e-CFR site at http://www.gpoaccess.gov/ecfr. To
access the harmonized test guidelines referenced in this document
electronically, please go to http://www.epa.gov/ocspp and select ``Test
Methods and Guidelines.''
C. How can I file an objection or hearing request?
Under FFDCA section 408(g), 21 U.S.C. 346a, any person may file an
objection to any aspect of this regulation and may also request a
hearing on those objections. You must file your objection or request a
hearing on this regulation in accordance with the instructions provided
in 40 CFR part 178. To ensure proper receipt by EPA, you must identify
docket ID number EPA-HQ-OPP-2009-0980 in the subject line on the first
page of your submission. All objections and requests for a hearing must
be in writing, and must be
[[Page 5697]]
received by the Hearing Clerk on or before April 4, 2011. Addresses for
mail and hand delivery of objections and hearing requests are provided
in 40 CFR 178.25(b).
In addition to filing an objection or hearing request with the
Hearing Clerk as described in 40 CFR part 178, please submit a copy of
the filing that does not contain any CBI for inclusion in the public
docket. Information not marked confidential pursuant to 40 CFR part 2
may be disclosed publicly by EPA without prior notice. Submit a copy of
your non-CBI objection or hearing request, identified by docket ID
number EPA-HQ-OPP-2009-0980, by one of the following methods:
Federal eRulemaking Portal: http://www.regulations.gov.
Follow the on-line instructions for submitting comments.
Mail: Office of Pesticide Programs (OPP) Regulatory Public
Docket (7502P), Environmental Protection Agency, 1200 Pennsylvania
Ave., NW., Washington, DC 20460-0001.
Delivery: OPP Regulatory Public Docket (7502P),
Environmental Protection Agency, Rm. S-4400, One Potomac Yard (South
Bldg.), 2777 S. Crystal Dr., Arlington, VA. Deliveries are only
accepted during the Docket Facility's normal hours of operation (8:30
a.m. to 4 p.m., Monday through Friday, excluding legal holidays).
Special arrangements should be made for deliveries of boxed
information. The Docket Facility telephone number is (703) 305-5805.
II. Summary of Petitioned-For Tolerances
In the Federal Register of January 6, 2010 (75 FR 864) (FRL-8801-
5), EPA issued a notice pursuant to section 408(d)(3) of FFDCA, 21
U.S.C. 346a(d)(3), announcing the filing of a pesticide petition (PP
9F7624) by Syngenta Crop Protection, Inc., P.O. Box 18300, Greensboro,
NC 27419-8300. The petition requested that 40 CFR 180.411 be amended by
establishing tolerances for residues of the herbicide, fluazifop-P-
butyl, in or on banana and plantains at 0.01 parts per million (ppm);
citrus (whole fruit), citrus (oil), and citrus (juice) at 0.05 ppm;
citrus (dried pulp) at 0.40 ppm; grapes at 0.01 ppm; sugarbeet (root)
at 0.25 ppm; sugarbeet (top) at 1.5 ppm; sugarbeet (dried pulp) at 1.0
ppm; and sugarbeet (molasses) at 3.5 ppm.
In the Federal Register of February 4, 2010 (75 FR 5790) (FRL-8807-
5), EPA issued a notice pursuant to section 408(d)(3) of FFDCA, 21
U.S.C. 346a(d)(3), announcing the filing of a pesticide petition (PP
9E7651) by Syngenta Crop Protection, Inc., P.O. Box 18300, Greensboro,
NC 27419-8300. The petition requested that 40 CFR 180.411 be amended by
establishing import tolerances for residues of fluazifop-P-butyl in or
on potato, tuber at 1.1 ppm; potato, peel (wet) at 1.1 ppm; potato,
chips at 3.0 ppm; and potato, granules/flakes at 5.0 ppm. That notice
incorrectly identified fluazifop-P-butyl as an insecticide. A corrected
notice, identifying fluazifop-P-butyl as an herbicide, was issued in
the Federal Register of March 10, 2010 (75 FR 11171) (FRL-8810-8).
Those notices referenced summaries of the petitions prepared by
Syngenta Crop Protection, Inc., the registrant, which are available in
the dockets (PP9F7641, docket ID number EPA-HQ-OPP-2009-0833; and
PP9E7651, docket ID number EPA-HQ-OPP-2009-0980), http://www.regulations.gov. There were no comments received in response to the
notices of filing.
Based upon review of the data supporting the petition, EPA has
determined that the proposed tolerances for plantains, sugarbeet (top),
and potato peel (wet) are unnecessary. EPA has also revised several of
the proposed commodity terms and tolerances levels, as well as the
proposed tolerance expression. The reasons for these changes are
explained in Unit IV.C.
III. Aggregate Risk Assessment and Determination of Safety
Section 408(b)(2)(A)(i) of FFDCA allows EPA to establish a
tolerance (the legal limit for a pesticide chemical residue in or on a
food) only if EPA determines that the tolerance is ``safe.'' Section
408(b)(2)(A)(ii) of FFDCA defines ``safe'' to mean that ``there is a
reasonable certainty that no harm will result from aggregate exposure
to the pesticide chemical residue, including all anticipated dietary
exposures and all other exposures for which there is reliable
information.'' This includes exposure through drinking water and in
residential settings, but does not include occupational exposure.
Section 408(b)(2)(C) of FFDCA requires EPA to give special
consideration to exposure of infants and children to the pesticide
chemical residue in establishing a tolerance and to ``ensure that there
is a reasonable certainty that no harm will result to infants and
children from aggregate exposure to the pesticide chemical residue. * *
*''
Consistent with section 408(b)(2)(D) of FFDCA, and the factors
specified in section 408(b)(2)(D) of FFDCA, EPA has reviewed the
available scientific data and other relevant information in support of
this action. EPA has sufficient data to assess the hazards of and to
make a determination on aggregate exposure for fluazifop-P-butyl
including exposure resulting from the tolerances established by this
action. EPA's assessment of exposures and risks associated with
fluazifop-P-butyl follows.
A. Toxicological Profile
EPA has evaluated the available toxicity data and considered its
validity, completeness, and reliability as well as the relationship of
the results of the studies to human risk. EPA has also considered
available information concerning the variability of the sensitivities
of major identifiable subgroups of consumers, including infants and
children.
In characterizing the toxicity of fluazifop-P-butyl, EPA considered
data on both fluazifop-P-butyl and fluazifop butyl. Fluazifop-P-butyl
is the resolved, herbicidally-active isomer (R enantiomer) of
fluazifop-butyl. The toxicity database for fluazifop-butyl is largely
complete with sufficient toxicity data on fluazifop-P-butyl to
demonstrate similar toxicity between the resolved and unresolved
compounds.
Fluazifop-P-butyl has low acute toxicity by the oral, dermal, and
inhalation routes of exposure. It is mildly irritating to the eye and
skin and is not a skin sensitizer. In repeated-dose studies, the liver
and kidney were the main target organs with toxicity expressed as liver
toxicity in the presence of peroxisome proliferation and exacerbation
of age-related kidney toxicity. The most sensitive endpoints were seen
in the rat (decreased testes and epididymal weights in male rats and
decreased pituitary and uterine weights in female rats), most likely
due to the longer retention time of the major metabolite (fluazifop
acid) in the rat. Fluazifop-P-butyl is classified as ``Not likely to be
carcinogenic to humans,'' based on the lack of evidence of
carcinogenicity in acceptable studies in rats and hamsters. The hamster
was selected for cancer study, rather than the mouse, because liver
peroxisome proliferation in hamsters more closely resembles what is
found for human liver cells. There is no evidence that fluazifop butyl
or fluazifop-P-butyl is mutagenic.
There was no evidence of neurotoxicity or neuropathology in the
available studies. Marginal increases in brain weights at termination
were observed in a sub-chronic toxicity study in rats and in a
carcinogenicity study performed on hamsters; however, they were only
seen at higher doses not considered relevant to human exposure.
The toxicity database for fluazifop-butyl and fluazifop-P-butyl
includes 7
[[Page 5698]]
developmental toxicity studies (5 in rats and 2 in rabbits) and a 2-
generation reproduction toxicity study in rats. Fetal effects
(including delayed ossification, delayed development of the urinary
tract, and diaphragmatic hernias) were consistent findings across the
five rat developmental toxicity studies. Maternal toxicity in these
studies was observed primarily as decreased weight/weight gain, with
maternal effects occurring at higher doses (100/300 milligram/kilogram/
day (mg/kg/day)) than doses resulting in fetal effects (2.0/5.0 mg/kg/
day). In the rabbit developmental studies, developmental effects
(nominal increases in delayed ossification, total litter loss,
abortions, small fetuses, and cloudy eyes in one study; and an
increased incidence of 13th rib and delayed ossification in sternebrae
2 in the second study) occurred at doses also causing maternal toxicity
(abortions, death, and weight loss). Similarly, in the reproduction
toxicity study in rats, offspring effects (decreased viability in the
F1 and F2 pups during lactational day 1, 4, 11,
18, and 25; and decreased F2 pup weight on lactational day
25) occurred at doses also resulting in parental toxicity (decreased
spleen weight in males and increased absolute and relative liver and
kidney weights and geriatric nephropathy in females). Reproductive
toxicity was observed in this study as decreased absolute and relative
testes and epididymal weight in males and, in females, decreased
pituitary and uterine weights.
For fluazifop, there were some indications of potential
immunotoxicity in the form of thymic involution, altered spleen
weights, lymphadenopathy and bone marrow myelogram changes in the
chronic toxicity study in dogs. The significance of these effects is
discussed in detail in Unit III.D.
Specific information on the studies received and the nature of the
adverse effects caused by fluazifop-P-butyl as well as the no-observed-
adverse-effect-level (NOAEL) and the lowest-observed-adverse-effect-
level (LOAEL) from the toxicity studies can be found at http://www.regulations.gov in the document ``Revised Fluazifop-P-Butyl.
Amended Human Health Risk Assessment to Support Use on Bananas, Citrus,
Grapes, Sugar Beets, and the Establishment of a Tolerance on Imported
Potatoes,'' pg. 60 in docket ID number EPA-HQ-OPP-2009-0980.
B. Toxicological Points of Departure/Levels of Concern
Once a pesticide's toxicological profile is determined, EPA
identifies toxicological points of departure (POD) and levels of
concern (LOC) to use in evaluating the risk posed by human exposure to
the pesticide. For hazards that have a threshold below which there is
no appreciable risk, the toxicological POD is used as the basis for
derivation of reference values for risk assessment. PODs are developed
based on a careful analysis of the doses in each toxicological study to
determine the dose at which no adverse effects are observed (the NOAEL)
and the lowest dose at which adverse effects of concern are identified
(the LOAEL). Uncertainty/safety factors are used in conjunction with
the POD to calculate a safe exposure level--generally referred to as a
population-adjusted dose (PAD) or a reference dose (RfD)--and a safe
margin of exposure (MOE). For non-threshold risks, the Agency assumes
that any amount of exposure will lead to some degree of risk. Thus, the
Agency estimates risk in terms of the probability of an occurrence of
the adverse effect expected in a lifetime. For more information on the
general principles EPA uses in risk characterization and a complete
description of the risk assessment process, see http://www.epa.gov/pesticides/factsheets/riskassess.htm.
A summary of the toxicological endpoints for fluazifop-P-butyl used
for human risk assessment is shown in Table 1 of this Unit.
Table 1--Summary of Toxicological Doses and Endpoints for Fluazifop-P-Butyl for Use in Human Health Risk
Assessment
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Point of departure and RfD, PAD, LOC for risk Study and toxicological
Exposure/scenario uncertainty/safety factors assessment effects
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Acute dietary (Females 13 to NOAEL = 50 milligrams/ Acute RfD = 0.50 mg/kg/day Developmental Toxicity in
50 years of age). kilograms/day (mg/kg/day) aPAD = 0.50mg/kg/day...... Rats.
UFA = 10x. Developmental LOAEL = 200
UFH = 10x................. mg/kg/day based on
FQPA SF = 1x.............. diaphragmatic hernia.
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Acute dietary (General An appropriate endpoint attributable to a single dose was not identified in the
population including infants available studies, including the developmental toxicity studies.
and children).
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Chronic dietary (All NOAEL= 0.74 mg/kg/day..... Chronic RfD = 0.0074 mg/kg/ 2-generation Reproduction
populations). UFA = 10x................. day. in Rats.
UFH = 10x................. cPAD = 0.0074 mg/kg/day... LOAEL = 5.8 mg/kg/day in
FQPA SF = 1x.............. males and 7.1 mg/kg/day
in females based on
decreased testes &
epididymal weights in
males, and uterine &
pituitary weights in
females.
Incidental oral short-term (1 NOAEL= 100 mg/kg/day...... LOC for MOE = 100......... Developmental Toxicity in
to 30 days). UFA = 10x................ Rats.
UFH = 10x................. Maternal LOAEL = 300 mg/
FQPA SF = 1x.............. kg/day based on maternal
body weight gain
decrement during GD 7-
16.
Incidental oral intermediate- NOAEL= 0.74 mg/kg/day..... LOC for MOE = 100......... 2-generation Reproduction
term (1 to 6 months). UFA= 10x................. in Rats.
UFH= 10x.................. Parental/systemic LOAEL =
FQPA SF = 1x.............. 5.8 mg/kg/day in males
and 7.1 mg/kg/day in
females based on
decreased testes &
epididymal weights in
males, and uterine &
pituitary weights in
females.
[[Page 5699]]
Dermal short-term (1 to 30 Oral study NOAEL = 2.0 mg/ LOC for MOE = 100......... Developmental Toxicity in
days). kg/day (dermal absorption Rats.
rate = 9% at 2 mg dose Developmental LOAEL = 5.0
and 2% at 200 mg dose.) mg/kg/day based on fetal
UFA = 10x................. weight decrement,
UFH = 10x................. hydroureter, and delayed
FQPA SF = 1x.............. ossification.
Dermal intermediate-term (1 Oral study NOAEL= 0.74 mg/ LOC for MOE = 100......... 2-generation Reproduction
to 6 months) and long-term kg/day (dermal absorption in Rats.
(<6 months). rate = 9% at 2 mg dose Parental/systemic LOAEL =
and 2% at 200 mg dose.) 5.8 mg/kg/day in males
UFA = 10x................. and 7.1 mg/kg/day in
UFH = 10x................. females based on
FQPA SF = 1x.............. decreased testes &
epididymal weights in
males, and uterine &
pituitary weights in
females.
Inhalation short-term (1 to Oral study NOAEL = 2.0 mg/ LOC for MOE = 100......... Developmental Toxicity in
30 days). kg/day (inhalation Rats
absorption rate = 100%). Developmental LOAEL = 5.0
UFA = 10x................. mg/kg/day based on fetal
UFH = 10x................. weight decrement,
FQPA SF = 1x.............. hydroureter, and delayed
ossification.
Intermediate-term (1 to 6 Oral study NOAEL = 0.74 mg/ LOC for MOE = 100......... 2-generation Reproduction
months) and long-term (<6 kg/day (inhalation in Rats.
months). absorption rate = 100%). Parental/systemic LOAEL =
UFA = 10x................. 5.8 mg/kg/day in males
UFH = 10x................. and 7.1 mg/kg/day in
FQPA SF = 1x.............. females based on
decreased testes &
epididymal weights in
males, and uterine &
pituitary weights in
females.
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Cancer (Oral, dermal, Not likely to be carcinogenic to humans.
inhalation).
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UFA = extrapolation from animal to human (interspecies). UFH = potential variation in sensitivity among members
of the human population (intraspecies). UFL = use of a LOAEL to extrapolate a NOAEL. UFS = use of a short-term
study for long-term risk assessment. UFDB = to account for the absence of data or other data deficiency. FQPA
SF = Food Quality Protection Act Safety Factor. PAD = population adjusted dose (a = acute, c = chronic). RfD =
reference dose. MOE = margin of exposure. LOC = level of concern.
C. Exposure Assessment
1. Dietary exposure from food and feed uses. In evaluating dietary
exposure to fluazifop-P-butyl, EPA considered exposure under the
petitioned-for tolerances as well as all existing fluazifop-P-butyl
tolerances in 40 CFR 180.411. EPA assessed dietary exposures from
fluazifop-P-butyl in food as follows:
i. Acute exposure. Quantitative acute dietary exposure and risk
assessments are performed for a food-use pesticide, if a toxicological
study has indicated the possibility of an effect of concern occurring
as a result of a 1-day or single exposure. Such effects were identified
for fluazifop-P-butyl for women of childbearing age (13 to 49 years
old). In estimating acute dietary exposure, EPA used food consumption
information from the U. S. Department of Agriculture (USDA) 1994-1996
Nationwide Continuing Surveys of Food Intakes by Individuals (CSFII).
As to residue levels in food, EPA assumed that all foods contain
tolerance-level residues (adjusted to account for all metabolites of
concern, based on the ratio of parent and metabolites found in plant
metabolism studies) and that 100% of all crops are treated with
fluazifop-P-butyl. Default processing factors were used to estimate
residues in processed commodities.
ii. Chronic exposure. In conducting the chronic dietary exposure
assessment EPA used the food consumption data from the USDA 1994-1996
and 1998 CSFII. As to residue levels in food, EPA assumed that residues
were present either at tolerance or average field trial levels. As in
the acute dietary exposure assessment, residue levels were adjusted to
account for all metabolites of concern. Percent crop treated (PCT) data
were used to refine exposure estimates for several currently registered
crop uses; 100 PCT was assumed for all new crop commodities. Default
processing factors were used to estimate residues in processed
commodities.
iii. Cancer. Based on the data summarized in Unit III.A., EPA has
concluded that fluazifop-P-butyl does not pose a cancer risk to humans.
Therefore, a dietary exposure assessment for the purpose of assessing
cancer risk is unnecessary.
iv. Anticipated residue and PCT information. Section 408(b)(2)(E)
of FFDCA authorizes EPA to use available data and information on the
anticipated residue levels of pesticide residues in food and the actual
levels of pesticide residues that have been measured in food. If EPA
relies on such information, EPA must require pursuant to FFDCA section
408(f)(1) that data be provided 5 years after the tolerance is
established, modified, or left in effect, demonstrating that the levels
in food are not above the levels anticipated. For the present action,
EPA will issue such data call-ins as are required by FFDCA section
408(b)(2)(E) and authorized under FFDCA section 408(f)(1). Data will be
required to be submitted no later than 5 years from the date of
issuance of these tolerances.
Section 408(b)(2)(F) of FFDCA states that the Agency may use data
on the actual percent of food treated for assessing chronic dietary
risk only if:
Condition a: The data used are reliable and provide a
valid basis to show what percentage of the food derived from such crop
is likely to contain the pesticide residue.
[[Page 5700]]
Condition b: The exposure estimate does not underestimate
exposure for any significant subpopulation group.
Condition c: Data are available on pesticide use and food
consumption in a particular area, the exposure estimate does not
understate exposure for the population in such area. In addition, the
Agency must provide for periodic evaluation of any estimates used. To
provide for the periodic evaluation of the estimate of PCT as required
by FFDCA section 408(b)(2)(F), EPA may require registrants to submit
data on PCT.
The Agency estimated the PCT for existing uses as follows:
Asparagus 2.5%; carrot 10%; cherry 1%; cottonseed 2.5%; dry beans 1%;
garlic 5%; onion (dry bulb) 15%; peach 2.5%; peanut 1%; pepper (non-
bell) 1%; and sweet potato 10%.
In most cases, EPA uses available data from the U. S. Department of
Agriculture/National Agricultural Statistics Service (USDA/NASS),
proprietary market surveys, and the National Pesticide Use Database for
the chemical/crop combination for the most recent 6 to7 years. EPA uses
an average PCT for chronic dietary risk analysis. The average PCT
figure for each existing use is derived by combining available public
and private market survey data for that use, averaging across all
observations, and rounding to the nearest 5%, except for those
situations in which the average PCT is less than one. In those cases,
1% is used as the average PCT and 2.5% is used as the maximum PCT. EPA
uses a maximum PCT for acute dietary risk analysis. The maximum PCT
figure is the highest observed maximum value reported within the recent
6 years of available public and private market survey data for the
existing use and rounded up to the nearest multiple of 5%.
The Agency believes that the three conditions discussed in Unit
III.C.1.iv. have been met. With respect to Condition a, PCT estimates
are derived from Federal and private market survey data, which are
reliable and have a valid basis. The Agency is reasonably certain that
the percentage of the food treated is not likely to be an
underestimation. As to Conditions b and c, regional consumption
information and consumption information for significant subpopulations
is taken into account through EPA's computer-based model for evaluating
the exposure of significant subpopulations including several regional
groups. Use of this consumption information in EPA's risk assessment
process ensures that EPA's exposure estimate does not understate
exposure for any significant subpopulation group and allows the Agency
to be reasonably certain that no regional population is exposed to
residue levels higher than those estimated by the Agency. Other than
the data available through national food consumption surveys, EPA does
not have available reliable information on the regional consumption of
food to which fluazifop-P-butyl may be applied in a particular area.
2. Dietary exposure from drinking water. The Agency used screening
level water exposure models in the dietary exposure analysis and risk
assessment for fluazifop-P-butyl in drinking water. These simulation
models take into account data on the physical, chemical, and fate/
transport characteristics of fluazifop-P-butyl. Further information
regarding EPA drinking water models used in pesticide exposure
assessment can be found at http://www.epa.gov/oppefed1/models/water/index.htm.
Based on the Pesticide Root Zone Model/Exposure Analysis Modeling
System (PRZM/EXAMS) and Screening Concentration in Ground Water (SCI-
GROW) models, the estimated drinking water concentrations (EDWCs) of
fluazifop-P-butyl for acute exposures are estimated to be 33.4 parts
per billion (ppb) for surface water and 1.56 ppb for ground water. The
EDWCs for chronic exposures for non-cancer assessments are estimated to
be 6.6 ppb for surface water and 1.56 ppb for ground water.
Modeled estimates of drinking water concentrations were directly
entered into the dietary exposure model. For acute dietary risk
assessment, the water concentration value of 33.4 ppb was used to
assess the contribution to drinking water. For chronic dietary risk
assessment, the water concentration of value 6.6 ppb was used to assess
the contribution to drinking water.
3. From non-dietary exposure. The term ``residential exposure'' is
used in this document to refer to non-occupational, non-dietary
exposure (e.g., for lawn and garden pest control, indoor pest control,
termiticides, and flea and tick control on pets).
Fluazifop-P-butyl is currently registered for the following uses
that could result in residential exposures: Turfgrass and broadleaf
ornamentals. EPA assessed residential exposure using the following
assumptions: Homeowners that apply fluazifop-P-butyl products may be
exposed to fluazifop-P-butyl for short-term durations via the dermal
and inhalation routes. There is also the potential for post-application
exposure of adults and children from activities on treated turf areas,
such as home lawns. Short-term dermal exposure of adults and children,
as well as incidental oral (hand-to-mouth, object-to-mouth, and soil
ingestion) exposure of children may occur. Further information
regarding EPA standard assumptions and generic inputs for residential
exposures may be found at http://www.epa.gov/pesticides/trac/science/trac6a05.pdf.
4. Cumulative effects from substances with a common mechanism of
toxicity. Section 408(b)(2)(D)(v) of FFDCA requires that, when
considering whether to establish, modify, or revoke a tolerance, the
Agency consider ``available information'' concerning the cumulative
effects of a particular pesticide's residues and ``other substances
that have a common mechanism of toxicity.'' EPA has not found
fluazifop-P-butyl to share a common mechanism of toxicity with any
other substances, and fluazifop-P-butyl does not appear to produce a
toxic metabolite produced by other substances. For the purposes of this
tolerance action, therefore, EPA has assumed that fluazifop-P-butyl
does not have a common mechanism of toxicity with other substances. For
information regarding EPA's efforts to determine which chemicals have a
common mechanism of toxicity and to evaluate the cumulative effects of
such chemicals, see EPA's Web site at http://www.epa.gov/pesticides/cumulative.
D. Safety Factor for Infants and Children
1. In general. Section 408(b)(2)(C) of FFDCA provides that EPA
shall apply an additional tenfold (10X) margin of safety for infants
and children in the case of threshold effects to account for prenatal
and postnatal toxicity, and the completeness of the database on
toxicity and exposure; unless EPA determines based on reliable data
that a different margin of safety will be safe for infants and
children. This additional margin of safety is commonly referred to as
the FQPA Safety Factor (SF). In applying this provision, EPA either
retains the default value of 10X, or uses a different additional safety
factor when reliable data available to EPA support the choice of a
different factor.
2. Prenatal and postnatal sensitivity. The pre- and postnatal
toxicity database for fluazifop/fluazifop-P-butyl includes five rat and
two rabbit developmental toxicity studies as well as a 2-generation
reproduction toxicity study in rats. As discussed in Unit III.A, there
was evidence of quantitative susceptibility of fetuses to fluazifop-P-
butyl exposure in the rat developmental toxicity studies. The degree of
concern for the increased susceptibility is low and there
[[Page 5701]]
is no residual uncertainty based on the following considerations: The
endpoint of concern (delayed ossifications) is considered to be a
developmental delay as opposed to a malformation or variation which
would be considered to be more serious in nature; there were
considerable variations in the incidences among the five rat studies;
the NOAELs/LOAELs for this effect were well defined and consistent
across these studies; and a developmental endpoint of concern
(diaphragmatic hernia) is used for assessing acute dietary risk. Also,
there was no evidence (quantitative or qualitative) of increased
susceptibility of fetuses or offspring in the rabbit developmental
studies or in the 2-generation rat reproduction toxicity study.
3. Conclusion. EPA has determined that reliable data show the
safety of infants and children would be adequately protected if the
FQPA SF were reduced to 1x. That decision is based on the following
findings:
i. The toxicity database for fluazifop-P-butyl is adequate to
assess pre- and postnatal toxicity, lacking only acute and sub-chronic
neurotoxicity studies and immunotoxicity testing. Ninety-day dermal and
inhalation toxicity studies are also required to confirm the PODs
selected for assessing dermal and inhalation exposures based on route-
to-route extrapolations from oral studies. EPA does not believe an
additional uncertainty factor is needed to account for the lack of
these studies for the following reasons:
a. Ninety-day dermal and inhalation studies. Fluazifop-P-butyl is
expected to show similar toxicity by the inhalation and oral routes
because of its metabolism by blood into the acid form and excretion in
this manner. Further, EPA selected a conservative (protective) POD from
a developmental toxicity study (NOAEL of 2.0 mg/kg/day) to assess both
short-term dermal and inhalation exposures. The NOAEL from the
available 28-day dermal study is considerably higher (100 mg/kg/day).
Although a POD from an oral study was used to assess residential
handler inhalation risks for fluazifop-P-butyl, EPA does not believe
this aggregate risk assessment is under-protective of adult handlers.
Handler MOEs based on the extrapolated endpoint are quite high (14,000
to 1.1 million), and the contribution of residential exposure to
aggregate risk is small. Therefore, even if an inhalation study were to
provide a lower POD than the oral study, it's not expected to have a
significant impact on aggregate risk.
b. Neurotoxicity. There was no evidence of neurotoxicity or
neuropathology in the available studies. Marginal increases in brain
weights at termination were observed in a sub-chronic toxicity study in
rats, and in a carcinogenicity study performed on hamsters; however,
they were only seen at higher doses not considered relevant to human
exposure.
c. Immunotoxicity. There were some indications of potential
immunotoxicity in the form of thymic involution, altered spleen
weights, lymphadenopathy and bone marrow myelogram changes in the
chronic toxicity study in dogs. EPA's concern for these effects is low,
based on the following considerations: Thymic involution was of slight
severity in only 1 female treated with the mid-dose; the response was
equivocal in the males, as there was no dose-response relationship
(incidence and severity) and controls also exhibited thymic involution.
One control dog had severe thymic involution; the statistical and
biological significance of the alterations in spleen weights could not
be assessed because of the large variation in the weights of control
dogs. Also, the alterations were inconsistent between dogs that died
(these dogs displayed increased adrenal weights) and dogs that survived
(these dogs displayed decreased adrenal weights); lymphadenopathy was
observed only at the high dose (125 mg/kg/day) and the response is
questionable, since the colony of dogs used in the study had excessive
health problems that included lymphadenopathy; the bone marrow
myelogram changes were small and variable and not considered dose-
related; and none of the potential immunological signs in the dog were
seen in the rat, the most sensitive species. For these reasons, EPA
considered the results of the chronic dog study to be unreliable. The
colony of dogs used in the study had excessive health problems that may
have impacted normal immune status, so that apparent immunotoxic
effects were observed even in some untreated control animals. Moreover,
no immunotoxic effects were observed in the sub-chronic dog study, a
study where healthy animals were used. EPA therefore concludes that the
available data do not warrant an additional uncertainty factor (UF) to
account for the lack of an immunotoxicity study.
ii. As noted previously in this unit, there is no indication that
fluazifop-P-butyl is a neurotoxic chemical and there is no need for a
developmental neurotoxicity study or additional UFs to account for
neurotoxicity.
iii. Although there is evidence of increased quantitative
susceptibility in in utero rats in the prenatal developmental studies,
the degree of concern for developmental effects is low, and EPA did not
identify any residual uncertainties after establishing toxicity
endpoints and traditional UFs to be used in the risk assessment of
fluazifop-P-butyl.
iv. There are no significant residual uncertainties identified in
the exposure databases. A citrus processing study and data on the
stability of fluazifop-P-butyl in processed potato commodities are
required; however, EPA does not expect these data to have a measurable
impact on exposure estimates for fluazifop-P-butyl. Data are available
which demonstrate fluazifop-P-butyl is stable in a wide variety of
frozen crop commodities, including potatoes. As such, EPA expects
fluazifop to be stable in frozen potato processed commodities but is
requiring data to confirm its stability in these fractions. The
submitted citrus processing study was determined to be inadequate and
EPA is, therefore, requiring that another study be conducted. In the
interim, EPA is establishing tolerances for processed citrus
commodities using worst-case concentration factors that will not
underestimate residues of fluazifop-P-butyl in these commodities.
The acute dietary food exposure assessment was performed based on
tolerance-level residues and 100 PCT. The chronic assessment was
refined for some commodities using reliable PCT information and
anticipated residues values calculated from guideline field trial
studies. EPA made conservative (protective) assumptions in the ground
and surface water modeling used to assess exposure to fluazifop-P-butyl
in drinking water. EPA used similarly conservative assumptions to
assess postapplication exposure of children as well as incidental oral
exposure of toddlers. These assessments will not underestimate the
exposure and risks posed by fluazifop-P-butyl.
E. Aggregate Risks and Determination of Safety
EPA determines whether acute and chronic dietary pesticide
exposures are safe by comparing aggregate exposure estimates to the
acute population adjusted dose (aPAD) and chronic population adjusted
dose (cPAD). For linear cancer risks, EPA calculates the lifetime
probability of acquiring cancer given the estimated aggregate exposure.
Short-, intermediate-, and chronic-term risks are evaluated by
comparing the estimated aggregate food, water, and residential exposure
to the appropriate PODs to ensure that an adequate MOE exists.
[[Page 5702]]
1. Acute risk. An acute aggregate risk assessment takes into
account acute exposure estimates from dietary consumption of food and
drinking water. Using the exposure assumptions discussed in this unit
for acute exposure, the acute dietary exposure from food and water to
fluazifop-P-butyl will occupy 13% of the aPAD for females 13 to 49
years old, the only population group for which an acute dietary
endpoint of concern was identified.
2. Chronic risk. Using the exposure assumptions described in this
unit for chronic exposure, EPA has concluded that chronic exposure to
fluazifop-P-butyl from food and water will utilize 40% of the cPAD for
children, 1 to 2 years old, the population group receiving the greatest
exposure. Based on the explanation in Unit III.C.3., regarding
residential use patterns, chronic residential exposure to residues of
fluazifop-P-butyl is not expected.
3. Short-term risk. Short-term aggregate exposure takes into
account short-term residential exposure plus chronic exposure to food
and water (considered to be a background exposure level). Fluazifop-P-
butyl is currently registered for uses that could result in short-term
residential exposure, and the Agency has determined that it is
appropriate to aggregate chronic exposure through food and water with
short-term residential exposures to fluazifop-P-butyl.
Using the exposure assumptions described in this unit for short-
term exposures, EPA has concluded the combined short-term food, water,
and residential exposures result in aggregate MOEs of 150 for adults
and 250 for children. The MOE for adults includes chronic exposure from
food and water plus short-term residential handler and post-application
exposure of adult females (the adult population with the highest
estimated exposure). The MOE for children includes chronic exposure
from food and water plus combined dermal and incidental oral short-
term, post-application exposures. Because EPA's level of concern for
fluazifop-P-butyl is a MOE of 100 or below, these MOEs are not of
concern.
4. Intermediate-term risk. Intermediate-term aggregate exposure
takes into account intermediate-term residential exposure plus chronic
exposure to food and water (considered to be a background exposure
level). An intermediate-term adverse effect was identified; however,
fluazifop-P-butyl is not registered for any use patterns that would
result in intermediate-term residential exposure. Intermediate-term
risk is assessed based on intermediate-term residential exposure plus
chronic dietary exposure. Because there is no intermediate-term
residential exposure and chronic dietary exposure has already been
assessed under the appropriately protective cPAD (which is at least as
protective as the POD used to assess intermediate-term risk), no
further assessment of intermediate-term risk is necessary, and EPA
relies on the chronic dietary risk assessment for evaluating
intermediate-term risk for fluazifop-P-butyl.
5. Aggregate cancer risk for U.S. population. Based on the lack of
evidence of carcinogenicity in two adequate rodent carcinogenicity
studies, fluazifop-P-butyl is not expected to pose a cancer risk to
humans.
6. Determination of safety. Based on these risk assessments, EPA
concludes that there is a reasonable certainty that no harm will result
to the general population, or to infants and children from aggregate
exposure to fluazifop-P-butyl residues.
IV. Other Considerations
A. Analytical Enforcement Methodology
Adequate enforcement methodology (High Performance Liquid
Chromatography/Ultra-Violet Spectrometry (HPLC/UV)) is available to
enforce the tolerance expression. The method is available in Pesticide
Analytical Methods (PAM), Volume II or may be requested from: Chief,
Analytical Chemistry Branch, Environmental Science Center, 701 Mapes
Rd., Ft. Meade, MD 20755-5350; telephone number: (410) 305-2905; e-mail
address: residuemethods@epa.gov.
B. International Residue Limits
In making its tolerance decisions, EPA seeks to harmonize U.S.
tolerances with international standards whenever possible, consistent
with U.S. food safety standards and agricultural practices. EPA
considers the international maximum residue limits (MRLs) established
by the Codex Alimentarius Commission (Codex), as required by FFDCA
section 408(b)(4). The Codex Alimentarius is a joint U.N. Food and
Agriculture Organization/World Health Organization food standards
program, and it is recognized as an international food safety
standards-setting organization in trade agreements to which the United
States is a party. EPA may establish a tolerance that is different from
a Codex MRL; however, FFDCA section 408(b)(4) requires that EPA explain
the reasons for departing from the Codex level.
The Codex has not established a MRL for fluazifop-P-butyl.
C. Revisions to Petitioned-For Tolerances
EPA has determined that the proposed tolerances for plantains,
sugarbeet (top), and potato peel (wet) are unnecessary. Residues of
fluazifop-P-butyl on plantains will be covered by the tolerance for
banana (40 CFR 180.1); and tolerances are no longer required for
sugarbeet tops, which were removed from the Table I (Significant
Feedstuffs Derived from Agricultural Crops Fed to Beef, Dairy, Poultry,
and Swine) of the residue chemistry guidelines (860.1000 OPPTS
Harmonized Test Guidelines) in June, 2008. A tolerance is not needed
for potato peel, since processing data demonstrate that residues do not
concentrate in the peel. Residues in the peel will, therefore, be
covered by the tolerance for potato.
EPA has also revised several of the proposed commodity terms and
tolerances levels. Commodity terms were revised as follows to comply
with the Agency's Food and Feed Vocabulary: ``Citrus (whole fruit),''
``grapes,'' ``potato tuber,'' ``sugarbeet (roots),'' ``sugarbeet (dried
pulp),'' and ``sugarbeet (molasses)'' were revised to read ``fruit,
citrus, group 10;'' ``grape;'' ``potato;'' ``beet, sugar, roots;''
``beet, sugar, dried pulp;'' and ``beet, sugar, molasses;''
respectively.
The proposed tolerance for citrus was reduced from 0.05 ppm to 0.03
ppm, the limit of quantitation (LOQ) of the residue analytical method,
since all field trial residues were below the LOQ. The citrus
processing study was inadequate for determining appropriate tolerances
in processed citrus commodities. Therefore, maximum theoretical
concentration factors were used in conjunction with the citrus field
trial results (all <0.03 ppm) to derive tolerances for citrus oil and
juice (proposed at 0.05 ppm) of 30.0 ppm and 0.06 ppm, respectively. A
maximum theoretical concentration factor is not available for citrus
pulp; however, a recent analysis of data for 27 different pesticides
showed concentration of residues in citrus pulp of between 2x and 13x.
EPA, therefore, used a concentration factor of 13x in conjunction with
field trial results to derive an appropriate tolerance of 0.40 ppm for
citrus pulp, the same level proposed by the petitioner.
Finally, EPA is revising the requested tolerance expression for
fluazifop-P-butyl in accordance with current Agency guidance. EPA is
also making this change for the existing fluazifop-P-butyl tolerances.
The revised tolerance expression makes clear that the tolerances cover
residues of the
[[Page 5703]]
herbicide fluazifop-P-butyl, including its metabolites and degradates,
but that compliance with the tolerance levels is to be determined by
measuring only the sum of fluazifop-P-butyl, butyl(R)-2-[4-[[5-
(trifluoromethyl)-2-pyridinyl]oxy]phenoxy]propanoate, and the free and
conjugated forms of the resolved isomer of fluazifop, (R)-2-[4-[[5-
(trifluoromethyl)-2-pyridinyl]oxy]phenoxy]propanoic acid, calculated as
the stoichiometric equivalent of fluazifop, in or on the commodity. EPA
has determined that it is reasonable to make this change final without
prior proposal and opportunity for comment, because public comment is
not necessary, in that the change has no substantive effect on the
tolerance, but rather is merely intended to clarify the existing
tolerance expression.
V. Conclusion
Therefore, tolerances are established for residues of fluazifop-P-
butyl, including its metabolites and degradates, in or on banana at
0.01 ppm; beet, sugar, dried pulp at 1.0 ppm; beet, sugar, molasses at
3.5 ppm; beet, sugar, roots at 0.25 ppm; citrus, dried pulp at 0.40
ppm; citrus, juice at 0.06 ppm; citrus, oil at 30.0 ppm; fruit, citrus,
group 10 at 0.03 ppm; grape at 0.01 ppm; potato at 1.0 ppm; potato,
chips at 2.0 ppm; and potato, granules/flakes at 4.0 ppm. Compliance
with the tolerance levels is to be determined by measuring only the sum
of fluazifop-P-butyl, butyl(R)-2-[4-[[5-(trifluoromethyl)-2-
pyridinyl]oxy]phenoxy]propanoate, and the free and conjugated forms of
the resolved isomer of fluazifop, (R)-2-[4-[[5-(trifluoromethyl)-2-
pyridinyl]oxy]phenoxy]propanoic acid, calculated as the stoichiometric
equivalent of fluazifop, in or on the commodity.
VI. Statutory and Executive Order Reviews
This final rule establishes tolerances under section 408(d) of
FFDCA in response to a petition submitted to the Agency. The Office of
Management and Budget (OMB) has exempted these types of actions from
review under Executive Order 12866, entitled Regulatory Planning and
Review (58 FR 51735, October 4, 1993). Because this final rule has been
exempted from review under Executive Order 12866, this final rule is
not subject to Executive Order 13211, entitled Actions Concerning
Regulations That Significantly Affect Energy Supply, Distribution, or
Use (66 FR 28355, May 22, 2001) or Executive Order 13045, entitled
Protection of Children from Environmental Health Risks and Safety Risks
(62 FR 19885, April 23, 1997). This final rule does not contain any
information collections subject to OMB approval under the Paperwork
Reduction Act (PRA), 44 U.S.C. 3501 et seq., nor does it require any
special considerations under Executive Order 12898, entitled Federal
Actions to Address Environmental Justice in Minority Populations and
Low-Income Populations (59 FR 7629, February 16, 1994).
Since tolerances and exemptions that are established on the basis
of a petition under section 408(d) of FFDCA, such as the tolerance in
this final rule, do not require the issuance of a proposed rule, the
requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et
seq.) do not apply.
This final rule directly regulates growers, food processors, food
handlers, and food retailers, not States or Tribes, nor does this
action alter the relationships or distribution of power and
responsibilities established by Congress in the preemption provisions
of section 408(n)(4) of FFDCA. As such, the Agency has determined that
this action will not have a substantial direct effect on States or
Tribal governments, on the relationship between the national government
and the States or Tribal governments, or on the distribution of power
and responsibilities among the various levels of government or between
the Federal Government and Indian Tribes. Thus, the Agency has
determined that Executive Order 13132, entitled Federalism (64 FR
43255, August 10, 1999) and Executive Order 13175, entitled
Consultation and Coordination with Indian Tribal Governments (65 FR
67249, November 9, 2000) do not apply to this final rule. In addition,
this final rule does not impose any enforceable duty or contain any
unfunded mandate as described under Title II of the Unfunded Mandates
Reform Act of 1995 (UMRA) (Pub. L. 104-4).
This action does not involve any technical standards that would
require Agency consideration of voluntary consensus standards pursuant
to section 12(d) of the National Technology Transfer and Advancement
Act of 1995 (NTTAA), Public Law 104-113, section 12(d) (15 U.S.C. 272
note).
VII. Congressional Review Act
The Congressional Review Act, 5 U.S.C. 801 et seq., generally
provides that before a rule may take effect, the agency promulgating
the rule must submit a rule report to each House of the Congress and to
the Comptroller General of the United States. EPA will submit a report
containing this rule and other required information to the U.S. Senate,
the U.S. House of Representatives, and the Comptroller General of the
United States prior to publication of this final rule in the Federal
Register. This final rule is not a ``major rule'' as defined by 5
U.S.C. 804(2).
List of Subjects in 40 CFR Part 180
Environmental protection, Administrative practice and procedure,
Agricultural commodities, Pesticides and pests, Reporting and
recordkeeping requirements.
Dated: January 18, 2011.
Lois Rossi,
Director, Registration Division, Office of Pesticide Programs.
Therefore, 40 CFR chapter I is amended as follows:
PART 180--[AMENDED]
0
1. The authority citation for part 180 continues to read as follows:
Authority: 21 U.S.C. 321(q), 346a and 371.
0
2. Section 180.411 is amended by revising paragraph (a) introductory
text and alphabetically adding the following commodities to the table
in paragraph (a) and revising paragraph (c) the introductory text to
read as follows:
Sec. 180.411 Fluazifop-P-butyl; tolerances for residues.
(a) General. Tolerances are established for residues of the
herbicide fluazifop-P-butyl, including its metabolites and degradates,
in or on the following commodities in the table. Compliance with the
tolerance levels specified in the table below is to be determined by
measuring only the sum of fluazifop-P-butyl, butyl(R)-2-[4-[[5-
(trifluoromethyl)-2-pyridinyl]oxy]phenoxy]propanoate, and the free and
conjugated forms of the resolved isomer of fluazifop, (R)-2-[4-[[5-
(trifluoromethyl)-2-pyridinyl]oxy]phenoxy]propanoic acid, calculated as
the stoichiometric equivalent of fluazifop, in or on the commodity.
------------------------------------------------------------------------
Parts per
Commodity million
------------------------------------------------------------------------
Banana..................................................... 0.01
* * * * *
Beet, sugar, dried pulp.................................... 1.0
Beet, sugar, molasses...................................... 3.5
Beet, sugar, roots......................................... 0.25
* * * * *
Citrus, dried pulp......................................... 0.40
Citrus, juice.............................................. 0.06
Citrus, oil................................................ 30.0
[[Page 5704]]
* * * * *
Fruit, citrus, group 10.................................... 0.03
* * * * *
Grape...................................................... 0.01
* * * * *
Potato\1\.................................................. 1.0
Potato, chips\1\........................................... 2.0
Potato, granules/flakes\1\................................. 4.0
* * * * *
------------------------------------------------------------------------
\1\ No U.S. registrations.
* * * * *
(c) Tolerances with regional registrations. Tolerances with
regional registrations are established for residues of the herbicide
fluazifop-P-butyl, including its metabolites and degradates, in or on
the following commodities in the table. Compliance with the tolerance
levels specified in the table below is to be determined by measuring
only the sum of fluazifop-P-butyl, butyl(R)-2-[4-[[5-(trifluoromethyl)-
2-pyridinyl]oxy]phenoxy]propanoate, and the free and conjugated forms
of the resolved isomer of fluazifop, (R)-2-[4-[[5-(trifluoromethyl)-2-
pyridinyl]oxy]phenoxy]propanoic acid, calculated as the stoichiometric
equivalent of fluazifop, in or on the commodity.
* * * * *
[FR Doc. 2011-1779 Filed 2-1-11; 8:45 am]
BILLING CODE 6560-50-P